Clinical Trials

The Naomi Berrie Diabetes Center is home to one of the country’s largest programs of clinical trials in diabetes. Our investigators work tirelessly to better understand the underlying causes of diabetes, and how this condition can be cured, prevented, and better controlled.

A clinical trial sets out to provide research scientists and doctors with answers to specific questions in a clinical setting. Patients who volunteer for clinical trials play an important role in helping find better ways to prevent, diagnose, or treat diabetes. Clinical trials are going on at the Berrie Center all the time. Feel free to discuss a trial with your doctor if you (or your child) fit the descriptions below.

Current Studies

Clinical trials are going on at the Berrie Center all the time. Here are some that are currently enrolling patients. 

TrialNet TN01: Pathway to Prevention Study

Purpose of study
To screen relatives of type 1 diabetes for the antibodies associated with a higher risk of developing type 1 diabetes. Autoantibodies are a sign that the immune system may be attacking the insulin-producing cells in the pancreas. View the related One-Sheeter for the study.

Who is eligible for this study?

  1. People 2 years 6 months of age to 45 years of age and have a brother, sister, child, or parent with type 1 diabetes.
  2. People 2 years 6 months of age to 20 years of age and have a cousin, aunt, uncle, niece, nephew, half-sibling, or grandchild with type 1 diabetes.

Time commitment

  • One-time blood test: Capillary (finger-prick) or Venipuncture (blood draw)
    • If tested positive, followed up annually or semi-annually until progression to Stage 3 T1D

Contact
James Pring at 212-851-5489 or email jp3735@cumc.columbia.edu

TrialNet TN27: TOPPLE T1D Study – Tolerance using Plasmid

Purpose of study
To investigate the safety and tolerability of ascending subcutaneous weekly doses of NNC0361-0041 plasmid in patients with T1D. This is a Phase 1 study.  It is the first time the therapy will be tested in people.  If the study results demonstrate that the investigational treatment is safe and impacts the immune system that causes type 1 diabetes, the hope is to study the drug in the future as a possible treatment for prevention of type 1 diabetes. View the related One-Sheeter for the study.

Who is eligible for this study?

  • You were diagnosed with type 1 diabetes within the last 48 months.
  • You will be at least 18 years old and at most 45 years old at the time of randomization in this trial.
  • Results of your screening tests show you are eligible.
  • You don’t have any medical conditions that might make it unsafe for you to be in this study.
  • You are not pregnant and do not plan to become pregnant while participating in the study.

Time commitment
1 year once enrolled. Additionally, there is a 48-hour inpatient visit followed by weekly visits for 12 weeks.

Reimbursement
Either $50 or $100 depending on the visit plus travel reimbursement

Contact
James Pring at 212-851-5489 or email jp3735@cumc.columbia.edu.

Type 1 Diabetes TrialNet Long-Term Investigative Follow-Up (LIFT) Study

Type of diabetes
Type 1 diabetes

Reimbursement
$25 per visit 

Contact
James Pring at 212-851-5489 or email jp3735@cumc.columbia.edu

Skeletal Health in Children with Type 1 Diabetes

Purpose of study
To learn how bone health is affected during the growth spurt in children and adolescents with type 1 diabetes. 

The study is investigating whether bone acquisition is impaired in children and adolescents with type 1 diabetes.  This might occur because high glucose levels can block bone-building activity.  Since the onset of type 1 diabetes is usually during childhood and adolescence, the period during which most of the adult bone mineral content is attained, the timing of the disease might reduce the “peak bone mass,” or the maximum amount of bone that a person can build during their life.  This might increase the risk of a fracture later in life.  

To investigate the impact of type 1 diabetes on bone accrual, the study compares baseline, 1 year and 2 year changes in bone structure, function and strength using bone density tests (dual energy X-ray absorptiometry and high resolution peripheral quantitative computed tomography with bone strength estimation) and blood tests (measuring bone building activity).  These tests are done in 40 children and adolescents with type 1 diabetes and in 40 children and adolescents without type 1 diabetes, beginning at the onset of the pubertal growth spurt. The study is also determining the relationships between changes in bone building and in measures of glycemic control, by using continuous glucose monitoring (CGM).   We expect that from this study information will be gained about how to maximize bone health in children and adolescents with type 1 diabetes during the critical window of peak bone development.   

Type of diabetes
Type 1 Diabetes

Age
8-16

Time commitment
3 in-person clinic visits over 2 years.  At each visit there is a blood draw and bone density tests. 

Reimbursement
$100.00 gift card for each clinic visit

Contact
Rukshana Majeed, research coordinator at 212-305-9489 or email rm3324@cumc.columbia.edu

RADIANT

Purpose of study
To discover and define rare and atypical forms of diabetes. These refined diagnoses will be used by diabetes researchers, physicians, and patients, to accurately explain their disease. This could also lead to better diagnoses, improved treatments, and potential prevention of these diseases. 

Who is eligible
You may be eligible for RADIANT if you have been diagnosed by your doctor with diabetes, but do not fit the usual patterns of type 1 or type 2. This may include the following characteristics or symptoms: 

  • Type 2 diabetes diagnosed in a child before the onset of puberty
  • Type 2 diabetes diagnosed in a person of any age who is not overweight 
  • Strong family history of diabetes in multiple generations, especially with early onset (<18 years old)
  • Negative type 1 diabetes autoantibodies
  • Evidence of beta cell function, that the body is still producing insulin, more than two years after diabetes diagnosis (you may need have a blood draw to determine this)
  • If you have had one or more episodes of diabetic ketoacidosis (DKA) but have been told you do NOT have type 1 diabetes, OR if you have had one or more episodes of DKA but are currently not requiring insulin therapy

Time commitment
The study has 3 stages. There are two venipuncture blood tests, completed once at the beginning of participation and again if advanced to Stage 2 of the study. If advanced to Stage 3, there is one in-person visit at a study site. Participation may last for several years. 

Contact
Kaisha Mofford at 212-851-5512 or email km3870@cumc.columbia.edu.

PRECIDENTD

Purpose of study
To learn more about SGLT2 inhibitors and GLP1 agonists, the only two classes of diabetes medications shown to reduce risk of heart disease for people with type 2 diabetes. We don’t know which medication class works better, or if taking both classes together works better than taking just one.

Who is eligible
People with type 2 diabetes who are:

  • Over age 40 and have had a heart attack, stroke, or stents to open their blood vessels.
  • Over age 60 with A1C above 8, or who smoke.

Time commitment

  • A 1-hour first visit in-person or by video conference. This will help make sure the medicines are safe and affordable for you. If you agree to participate, you will complete questionnaires, have your height and weight taken, and be assigned your medication.
  • Follow-up visit or call with study team two months later.
  • One survey per year by phone or online between the yearly visits until the study ends in 2028.
  • One in-person or video conference visit per year until the study ends in 2028. 

Reimbursement
You will be paid $100 for each year that you take part in the study.

Contact
James Pring at 212-851-5489 or email jp3735@cumc.columbia.edu and Anabel Evans at 212-851-5492 or email ae2816@cumc.columbia.edu.

Contact Us

For more information about our clinical trials, please contact James Pring, senior type 2 diabetes clinical trial coordinator (212-851-5489jp3735@cumc.columbia.edu).

Our Clinical Team

You hear a lot these days about how little time a physician spends with a patient. We turn that model inside out. The Berrie Center team takes the time to get to know our patients and individualize their care, which translates into much better diabetes control.

Meet Our Team